GMP Lipid Nanoparticle Production

The problem

Once you’ve finessed your formulation and perfected your particle production process in the R&D lab, it’s time for clinical trials – which means tackling the transition to GMP lipid nanoparticle manufacturing. Too often, this involves revalidating your LNP production process on entirely new kit, with different pumps and mixer types. To make matters worse, this revalidation can mean wasting a bunch of your precious reagents and burning through expensive, single-use consumables. 

The right tool for the job

With the Sunny Suite, each instrument is built on the same, precise pumping technology and world-class, re-usable Sunnies to mix up your formulations; so whether you’re screening formulations on Sunscreen, optimizing your process on Sunshine, or turning on the taps for your clinical trials in a GMP-compliant facility with Sunbather, you can be confident in a swift and seamless transfer of your process from R&D to manufacturing. With a range of Sunny mixing types and sizes available, there’s a path to production for every application. 

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The proof

Keep it compliant

Sunbather makes sure you're covered where it counts, allowing you to effortlessly dive into GMP lipid nanoparticle manufacturing and begin churning out liters of your perfect particles. Sunbather manufacturing is secured by our internal Quality Management System (QMS), and with 21 CFR Part 11 compliant software, full traceability of wetted materials and extractables data on deck, you can be confident that Sunbather has all your bases covered when it comes to GMP LNP production.  

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Consistency is key

Sunbather keeps things consistent with the same outstanding particle performance from run to run as Sunscreenand Sunshine, giving you confidence transitioning from microliters to liters using the same mixing process. The Sunny Suite uniquely offers a single consistent process from automated screening of a few hundred microliters right through to continuous LNP production of liters of quality product. The data speaks for itself; reproducibility across every stage of your development. 

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Transferring your LNPs to GMP can be a costly, messy process. It usually means switching equipment, using a different flow path and mixer — basically a painful re‑development and re-validation of all your hard work. Sunbather makes the move to GMP a walk in the park with the documentation, replaceable flow path and easy transfer built right in. It uses the same mixing process and protocol as its Sunny Suite family members Sunscreen and Sunshine, so you can take your dialed in formulation into GMP without all the fuss.

Want more info?

Want to learn more about how Sunbather helps you with lipid nanoparticle production in GMP environments?